... on 'State of the Art in Assessing Research Impact', and to be asked to offer some c... more ... on 'State of the Art in Assessing Research Impact', and to be asked to offer some comments on the papers, the work-shop, and the ... I ... The forthcoming roll-out of the REF in the UK of-fers an excellent opportunity to address this gap, and policy-makers should now be reaching out ...
The Canadian healthcare system is undergoing restructuring of how goods and services are purchase... more The Canadian healthcare system is undergoing restructuring of how goods and services are purchased. A conference "Navigating Hospital and Health System Procurement" was organized by MEDEC and the Canadian College of Health Leaders to examine the issues. This paper describes the implications and opportunities these changes present for healthcare policy, regulation, practice, and the supplier marketplace.
To address the uncertainty associated with procuring pharmaceutical products, product listing agr... more To address the uncertainty associated with procuring pharmaceutical products, product listing agreements (PLAs) are increasingly being used to support responsible funding decisions in Canada and elsewhere. These agreements typically involve financial-based rebating initiatives or, less frequently, outcome-based contracts. A qualitative survey was conducted to improve the understanding of outcome-based and more innovative PLAs (IPLAs) based on input from Canadian and international key opinion leaders in the areas of drug manufacturing and reimbursement. Results from a structured literature review were used to inform survey development. Potential participants were invited via email to partake in the survey, which was conducted over phone or in person. Responses were compiled anonymously for review and reporting. Twenty-one individuals participated in the survey, including health technology assessment (HTA) key opinion leaders (38%), pharmaceutical industry chief executive officers/vice presidents (29%), ex-payers (19%), and current payers/drug plan managers/HTA (14%). The participants suggested that ~80%-95% of Canadian PLAs are financial-based rather than outcomes-based. They indicated that IPLAs offer important benefits to patients, payers, and manufacturers; however, several challenges limit their use (eg, administrative burden, lack of agreed-upon endpoint). They noted that IPLAs are useful in rapidly evolving therapeutic areas and those associated with high unmet need, a quantifiable endpoint, and/or robust data systems. The Canadian Agency for Drugs and Technologies in Health, the pan-Canadian Pharmaceutical Alliance, and other arms-length organizations could play important roles in identifying uncertainty and endpoints and brokering pan-Canadian PLAs. Industry should work collaboratively with payers to identify uncertainty and develop innovative mechanisms to address it. The survey results indicated that while challenging, use of IPLAs may be associated with various benefits. Collaboration among stakeholders remains key: Canadian agencies could play an important role in the success of these agreements, while industry should be proactive in offering solutions that will help improve outcomes across the entire health care system.
Journal of health organization and management, Jan 15, 2016
Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance consideratio... more Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance considerations of innovation, clinical evidence, budget impact and equity in health priority-setting. The purpose of this paper is to examine the role of public participation in addressing these considerations. Design/methodology/approach - The paper employs a comparative case study approach. It explores the experience of four countries - Brazil, England, South Korea and the USA - in making coverage decisions about the antiviral sofosbuvir and involving the public and patients in these decision-making processes. Findings - Issues emerging from public participation ac tivities include the role of the universal right to health in Brazil, the balance between innovation and budget impact in England, the effect of unethical medical practices on public perception in South Korea and the legitimacy of priority-setting processes in the USA. Providing policymakers are receptive to these issues, public partici...
International journal of technology assessment in health care, 2015
Health Technology Assessment (HTA) needs to address the challenges posed by high cost, effective ... more Health Technology Assessment (HTA) needs to address the challenges posed by high cost, effective technologies, expedited regulatory approaches, and the opportunities provided by collaborative real-world evaluation of technologies. The Health Technology Assessment International (HTAi) Policy Forum met to consider these issues and the implications for evidence production to inform HTA. This paper shares their discussion to stimulate further debate. A background paper, presentations, group discussions, and stakeholder role play at the 2015 HTAi Policy Forum meeting informed this paper. HTA has an important role to play in helping improve evidence production and ensuring that the health service is ready to adopt effective technologies. It needs to move from simply informing health system decisions to also working actively to align stakeholder expectations about realistic evidence requirements. Processes to support dialogue over the health technology life cycle need to be developed that ...
International journal of technology assessment in health care, 2015
Are we in a period of significant change? Is health technology assessment (HTA) undergoing a fund... more Are we in a period of significant change? Is health technology assessment (HTA) undergoing a fundamental transformation? Or should it be? Are we in the middle of a paradigm shift? These are some of the questions the paper by Facey et al in this journal (1) raises about the future of HTA, based on discussions at the HTAi Policy Forum in February 2015. To further share the deliberations of the Forum and with a view to opening this debate among the wider HTA community, a panel within the HTAi 2015 Annual Meeting in Oslo was organized. Presentations at the panel included a summary of the HTAi Policy Forum deliberations and perspectives from a patient, a clinician, and representatives of an HTA organization, industry, and a health system. This letter presents issues and thoughts raised in the panel session.
Health research policy and systems / BioMed Central, 2015
The time taken, or 'time lags', between biomedical/health research and its translation in... more The time taken, or 'time lags', between biomedical/health research and its translation into health improvements is receiving growing attention. Reducing time lags should increase rates of return to such research. However, ways to measure time lags are under-developed, with little attention on where time lags arise within overall timelines. The process marker model has been proposed as a better way forward than the current focus on an increasingly complex series of translation 'gaps'. Starting from that model, we aimed to develop better methods to measure and understand time lags and develop ways to identify policy options and produce recommendations for future studies. Following reviews of the literature on time lags and of relevant policy documents, we developed a new approach to conduct case studies of time lags. We built on the process marker model, including developing a matrix with a series of overlapping tracks to allow us to present and measure elements within...
International Journal of Technology Assessment in Health Care, 2012
Health systems face rising patient expectations and economic pressures; decision makers seek to e... more Health systems face rising patient expectations and economic pressures; decision makers seek to enhance efficiency to improve access to appropriate care. There is international interest in the role of HTA to support decisions to optimize use of established technologies, particularly in "disinvesting" from low-benefit uses. This study summarizes main points from an HTAi Policy Forum meeting on this topic, drawing on presentations, discussions among attendees, and an advance background paper. Optimization involves assessment or re-assessment of a technology, a decision on optimal use, and decision implementation. This may occur within a routine process to improve safety and quality and create "headroom" for new technologies, or ad hoc in response to financial constraints. The term "disinvestment" is not always helpful in describing these processes. HTA contributes to optimization, but there is scope to increase its role in many systems. Stakeholders may have strong views on access to technology, and stakeholder involvement is essential. Optimization faces challenges including loss aversion and entitlement, stakeholder inertia and entrenchment, heterogeneity in patient outcomes, and the need to demonstrate convincingly absence of benefit. While basic HTA principles remain applicable, methodological developments are needed better to support optimization. These include mechanisms for candidate technology identification and prioritization, enhanced collection and analysis of routine data, and clinician engagement. To maximize value to decision makers, HTA should consider implementation strategies and barriers. Improving optimization processes calls for a coordinated approach, and actions are identified for system leaders, HTA and other health organizations, and industry.
International Journal of Technology Assessment in Health Care, 2007
The application of conditionality to coverage decisions for healthcare technologies is increasing... more The application of conditionality to coverage decisions for healthcare technologies is increasing. Coverage with Evidence Development (CED) represents a specific approach to coverage for promising technologies for which the evidence remains uncertain. CED demands that additional evidence is generated to address the sources of uncertainty and secure ongoing coverage. This study explores the conceptual and policy issues relating to CED and discusses issues involved in operationalizing CED in practice, including presenting criteria for which technologies may be most suitable for CED. This study is intended to further the debate on the use of CED as well as highlight areas that warrant further research.
International Journal of Technology Assessment in Health Care, 2006
Objectives: Australia, Canada, and many European countries now use various forms of health techno... more Objectives: Australia, Canada, and many European countries now use various forms of health technology assessment (HTA) in decision making regarding the reimbursement of drugs and other health technologies. To achieve a better understanding of the potential for use of HTA in this context, an analytical framework was developed to describe and classify existing fourth hurdle systems. Methods: Based on a review of published literature, and official documentation, the key aspects of a fourth hurdle system were identified at two levels: policy implementation and individual technology decision. Characteristics of the systems were grouped under four main headings: constitution and governance, objectives, use of evidence and decision processes, and accountability. The comprehensiveness and relevance of this framework was assessed by an independent group of experts in HTA. A pilot study was undertaken,
International Journal of Technology Assessment in Health Care, 2014
Adaptive approaches to the introduction of drugs and medical devices involve the use of an evolvi... more Adaptive approaches to the introduction of drugs and medical devices involve the use of an evolving evidence base rather than conventional single-point-in-time evaluations as a proposed means to promote patient access to innovation, reduce clinical uncertainty, ensure effectiveness, and improve the health technology development process. This report summarizes a Health Technology Assessment International (HTAi) Policy Forum discussion, drawing on presentations from invited experts, discussions among attendees about real-world case examples, and background paper. For adaptive approaches to be understood, accepted, and implemented, the Forum identified several key issues that must be addressed. These include the need to define the goals of and to set priorities for adaptive approaches; to examine evidence collection approaches; to clarify the roles and responsibilities of stakeholders; to understand the implications of adaptive approaches on current legal and ethical standards; to determine costs of such approaches and how they will be met; and to identify differences in applying adaptive approaches to drugs versus medical devices. The Forum also explored the different implications of adaptive approaches for various stakeholders, including patients, regulators, HTA/coverage bodies, health systems, clinicians, and industry. A key outcome of the meeting was a clearer understanding of the opportunities and challenges adaptive approaches present. Furthermore, the Forum brought to light the critical importance of recognizing and including a full range of stakeholders as contributors to a shared decision-making model implicit in adaptive pathways in future discussions on, and implementation of, adaptive approaches.
International Journal of Technology Assessment in Health Care, 2000
The National Health Service (NHS) provides universal health coverage for all British citizens. Mo... more The National Health Service (NHS) provides universal health coverage for all British citizens. Most services are free of charge, although modest copayments are sometimes applied. About 11% of the population also has private insurance. General practitioners, generally the first point of contact for accessing the system, are independent contractors who serve as gatekeepers for specialist and hospital services and enjoy substantial clinical autonomy. Hospitals are public and are regionalized, but the 1990 reforms made them self-governing trusts that contract with local purchasers (health authorities and general practitioner fundholders). Reforms beginning in 1990 moved the NHS away from a centralized administrative structure to more pluralistic arrangements in which competition, as well as management, influences how services develop. Health technology and health technology assessment (HTA) have gained increasing attention in the NHS during this period, as part of a wider NHS Research and Development (R&D) Strategy. The strategy promotes a knowledge-based health service with a strong research infrastructure and the capacity to critically review its own needs. HTA is the largest and most developed of the programs within the strategy. It has a formal system for setting assessment priorities involving widespread consultation within the NHS, and a National Co-ordinating Centre for Health Technology Assessment. The strategy supports related centers such as the U.K. Cochrane Centre and the NHS Centre for Reviews and Dissemination. A hallmark of the HTA program is strong public participation. The United Kingdom has made a major commitment to HTA and to seeking effective means of reviewing and disseminating evidence.
International Journal of Technology Assessment in Health Care, 2011
The relationship between regulatory approval on the one hand and health technology assessment (HT... more The relationship between regulatory approval on the one hand and health technology assessment (HTA) and coverage on the other is receiving growing attention. Those responsible for regulatory approval, HTA, and coverage have different missions and their information requirements reflect these. There is nonetheless an increasingly popular view that improved communication and coordination between these functions could allow them all to be undertaken effectively with a lower overall burden of evidence requirements, thus speeding patient access to new products and reducing unnecessary barriers to innovation. This study summarizes the main points emerging from a recent discussion of this topic at the HTAi Policy Forum. After considering the roles of the various bodies, stakeholder perspectives and some current practical initiatives, those present at the Forum meeting discussed possible goals and challenges for improved interactions-in general and at specific stages of the product development life cycle. Opportunities for progress were seen in: continuing the dialogue to promote understanding and interaction between the different bodies and stakeholders; working to align scientific advice for manufacturers on the design and data requirements of pre- and post-marketing evaluation of products (specifically phase 2/3 and phase 4 trials for drugs); and extending the current dialogue to include discussion of product development to address unmet health needs.
International Journal of Technology Assessment in Health Care, 2013
Background: Identifying treatments that offer value and value for money is becoming increasingly ... more Background: Identifying treatments that offer value and value for money is becoming increasingly important, with interest in how health technology assessment (HTA) and decision makers can take appropriate account of what is of value to patients and to society, and in the relationship between innovation and assessments of value. Methods: This study summarizes points from an Health Technology Assessment International (HTAi) Policy Forum discussion, drawing on presentations, discussions among attendees, and background papers. Results and Conclusions: Various perspectives on value were considered; most place patient health at the core of value. Wider elements of value comprise other benefits for: patients; caregivers; the health and social care systems; and society. Most decision-making systems seek to take account of similar elements of value, although they are assessed and combined in different ways. Judgment in decisions remains important and cannot be replaced by mathematical approaches. There was discussion of the value of innovation and of the effects of value assessments on innovation. Discussion also included moving toward "progressive health system decision making," an ongoing process whereby evidence-based decisions on use would be made at various stages in the technology lifecycle. Five actions are identified: (i) development of a general framework for the definition and assessment of value; development by HTA/coverage bodies and regulators of (ii) disease-specific guidance and (iii) further joint scientific advice for industry on demonstrating value; (iv) development of a framework for progressive licensing, usage, and reimbursement; and (v) promoting work to better adapt HTA, coverage, and procurement approaches to medical devices.
... on 'State of the Art in Assessing Research Impact', and to be asked to offer some c... more ... on 'State of the Art in Assessing Research Impact', and to be asked to offer some comments on the papers, the work-shop, and the ... I ... The forthcoming roll-out of the REF in the UK of-fers an excellent opportunity to address this gap, and policy-makers should now be reaching out ...
The Canadian healthcare system is undergoing restructuring of how goods and services are purchase... more The Canadian healthcare system is undergoing restructuring of how goods and services are purchased. A conference "Navigating Hospital and Health System Procurement" was organized by MEDEC and the Canadian College of Health Leaders to examine the issues. This paper describes the implications and opportunities these changes present for healthcare policy, regulation, practice, and the supplier marketplace.
To address the uncertainty associated with procuring pharmaceutical products, product listing agr... more To address the uncertainty associated with procuring pharmaceutical products, product listing agreements (PLAs) are increasingly being used to support responsible funding decisions in Canada and elsewhere. These agreements typically involve financial-based rebating initiatives or, less frequently, outcome-based contracts. A qualitative survey was conducted to improve the understanding of outcome-based and more innovative PLAs (IPLAs) based on input from Canadian and international key opinion leaders in the areas of drug manufacturing and reimbursement. Results from a structured literature review were used to inform survey development. Potential participants were invited via email to partake in the survey, which was conducted over phone or in person. Responses were compiled anonymously for review and reporting. Twenty-one individuals participated in the survey, including health technology assessment (HTA) key opinion leaders (38%), pharmaceutical industry chief executive officers/vice presidents (29%), ex-payers (19%), and current payers/drug plan managers/HTA (14%). The participants suggested that ~80%-95% of Canadian PLAs are financial-based rather than outcomes-based. They indicated that IPLAs offer important benefits to patients, payers, and manufacturers; however, several challenges limit their use (eg, administrative burden, lack of agreed-upon endpoint). They noted that IPLAs are useful in rapidly evolving therapeutic areas and those associated with high unmet need, a quantifiable endpoint, and/or robust data systems. The Canadian Agency for Drugs and Technologies in Health, the pan-Canadian Pharmaceutical Alliance, and other arms-length organizations could play important roles in identifying uncertainty and endpoints and brokering pan-Canadian PLAs. Industry should work collaboratively with payers to identify uncertainty and develop innovative mechanisms to address it. The survey results indicated that while challenging, use of IPLAs may be associated with various benefits. Collaboration among stakeholders remains key: Canadian agencies could play an important role in the success of these agreements, while industry should be proactive in offering solutions that will help improve outcomes across the entire health care system.
Journal of health organization and management, Jan 15, 2016
Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance consideratio... more Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance considerations of innovation, clinical evidence, budget impact and equity in health priority-setting. The purpose of this paper is to examine the role of public participation in addressing these considerations. Design/methodology/approach - The paper employs a comparative case study approach. It explores the experience of four countries - Brazil, England, South Korea and the USA - in making coverage decisions about the antiviral sofosbuvir and involving the public and patients in these decision-making processes. Findings - Issues emerging from public participation ac tivities include the role of the universal right to health in Brazil, the balance between innovation and budget impact in England, the effect of unethical medical practices on public perception in South Korea and the legitimacy of priority-setting processes in the USA. Providing policymakers are receptive to these issues, public partici...
International journal of technology assessment in health care, 2015
Health Technology Assessment (HTA) needs to address the challenges posed by high cost, effective ... more Health Technology Assessment (HTA) needs to address the challenges posed by high cost, effective technologies, expedited regulatory approaches, and the opportunities provided by collaborative real-world evaluation of technologies. The Health Technology Assessment International (HTAi) Policy Forum met to consider these issues and the implications for evidence production to inform HTA. This paper shares their discussion to stimulate further debate. A background paper, presentations, group discussions, and stakeholder role play at the 2015 HTAi Policy Forum meeting informed this paper. HTA has an important role to play in helping improve evidence production and ensuring that the health service is ready to adopt effective technologies. It needs to move from simply informing health system decisions to also working actively to align stakeholder expectations about realistic evidence requirements. Processes to support dialogue over the health technology life cycle need to be developed that ...
International journal of technology assessment in health care, 2015
Are we in a period of significant change? Is health technology assessment (HTA) undergoing a fund... more Are we in a period of significant change? Is health technology assessment (HTA) undergoing a fundamental transformation? Or should it be? Are we in the middle of a paradigm shift? These are some of the questions the paper by Facey et al in this journal (1) raises about the future of HTA, based on discussions at the HTAi Policy Forum in February 2015. To further share the deliberations of the Forum and with a view to opening this debate among the wider HTA community, a panel within the HTAi 2015 Annual Meeting in Oslo was organized. Presentations at the panel included a summary of the HTAi Policy Forum deliberations and perspectives from a patient, a clinician, and representatives of an HTA organization, industry, and a health system. This letter presents issues and thoughts raised in the panel session.
Health research policy and systems / BioMed Central, 2015
The time taken, or 'time lags', between biomedical/health research and its translation in... more The time taken, or 'time lags', between biomedical/health research and its translation into health improvements is receiving growing attention. Reducing time lags should increase rates of return to such research. However, ways to measure time lags are under-developed, with little attention on where time lags arise within overall timelines. The process marker model has been proposed as a better way forward than the current focus on an increasingly complex series of translation 'gaps'. Starting from that model, we aimed to develop better methods to measure and understand time lags and develop ways to identify policy options and produce recommendations for future studies. Following reviews of the literature on time lags and of relevant policy documents, we developed a new approach to conduct case studies of time lags. We built on the process marker model, including developing a matrix with a series of overlapping tracks to allow us to present and measure elements within...
International Journal of Technology Assessment in Health Care, 2012
Health systems face rising patient expectations and economic pressures; decision makers seek to e... more Health systems face rising patient expectations and economic pressures; decision makers seek to enhance efficiency to improve access to appropriate care. There is international interest in the role of HTA to support decisions to optimize use of established technologies, particularly in "disinvesting" from low-benefit uses. This study summarizes main points from an HTAi Policy Forum meeting on this topic, drawing on presentations, discussions among attendees, and an advance background paper. Optimization involves assessment or re-assessment of a technology, a decision on optimal use, and decision implementation. This may occur within a routine process to improve safety and quality and create "headroom" for new technologies, or ad hoc in response to financial constraints. The term "disinvestment" is not always helpful in describing these processes. HTA contributes to optimization, but there is scope to increase its role in many systems. Stakeholders may have strong views on access to technology, and stakeholder involvement is essential. Optimization faces challenges including loss aversion and entitlement, stakeholder inertia and entrenchment, heterogeneity in patient outcomes, and the need to demonstrate convincingly absence of benefit. While basic HTA principles remain applicable, methodological developments are needed better to support optimization. These include mechanisms for candidate technology identification and prioritization, enhanced collection and analysis of routine data, and clinician engagement. To maximize value to decision makers, HTA should consider implementation strategies and barriers. Improving optimization processes calls for a coordinated approach, and actions are identified for system leaders, HTA and other health organizations, and industry.
International Journal of Technology Assessment in Health Care, 2007
The application of conditionality to coverage decisions for healthcare technologies is increasing... more The application of conditionality to coverage decisions for healthcare technologies is increasing. Coverage with Evidence Development (CED) represents a specific approach to coverage for promising technologies for which the evidence remains uncertain. CED demands that additional evidence is generated to address the sources of uncertainty and secure ongoing coverage. This study explores the conceptual and policy issues relating to CED and discusses issues involved in operationalizing CED in practice, including presenting criteria for which technologies may be most suitable for CED. This study is intended to further the debate on the use of CED as well as highlight areas that warrant further research.
International Journal of Technology Assessment in Health Care, 2006
Objectives: Australia, Canada, and many European countries now use various forms of health techno... more Objectives: Australia, Canada, and many European countries now use various forms of health technology assessment (HTA) in decision making regarding the reimbursement of drugs and other health technologies. To achieve a better understanding of the potential for use of HTA in this context, an analytical framework was developed to describe and classify existing fourth hurdle systems. Methods: Based on a review of published literature, and official documentation, the key aspects of a fourth hurdle system were identified at two levels: policy implementation and individual technology decision. Characteristics of the systems were grouped under four main headings: constitution and governance, objectives, use of evidence and decision processes, and accountability. The comprehensiveness and relevance of this framework was assessed by an independent group of experts in HTA. A pilot study was undertaken,
International Journal of Technology Assessment in Health Care, 2014
Adaptive approaches to the introduction of drugs and medical devices involve the use of an evolvi... more Adaptive approaches to the introduction of drugs and medical devices involve the use of an evolving evidence base rather than conventional single-point-in-time evaluations as a proposed means to promote patient access to innovation, reduce clinical uncertainty, ensure effectiveness, and improve the health technology development process. This report summarizes a Health Technology Assessment International (HTAi) Policy Forum discussion, drawing on presentations from invited experts, discussions among attendees about real-world case examples, and background paper. For adaptive approaches to be understood, accepted, and implemented, the Forum identified several key issues that must be addressed. These include the need to define the goals of and to set priorities for adaptive approaches; to examine evidence collection approaches; to clarify the roles and responsibilities of stakeholders; to understand the implications of adaptive approaches on current legal and ethical standards; to determine costs of such approaches and how they will be met; and to identify differences in applying adaptive approaches to drugs versus medical devices. The Forum also explored the different implications of adaptive approaches for various stakeholders, including patients, regulators, HTA/coverage bodies, health systems, clinicians, and industry. A key outcome of the meeting was a clearer understanding of the opportunities and challenges adaptive approaches present. Furthermore, the Forum brought to light the critical importance of recognizing and including a full range of stakeholders as contributors to a shared decision-making model implicit in adaptive pathways in future discussions on, and implementation of, adaptive approaches.
International Journal of Technology Assessment in Health Care, 2000
The National Health Service (NHS) provides universal health coverage for all British citizens. Mo... more The National Health Service (NHS) provides universal health coverage for all British citizens. Most services are free of charge, although modest copayments are sometimes applied. About 11% of the population also has private insurance. General practitioners, generally the first point of contact for accessing the system, are independent contractors who serve as gatekeepers for specialist and hospital services and enjoy substantial clinical autonomy. Hospitals are public and are regionalized, but the 1990 reforms made them self-governing trusts that contract with local purchasers (health authorities and general practitioner fundholders). Reforms beginning in 1990 moved the NHS away from a centralized administrative structure to more pluralistic arrangements in which competition, as well as management, influences how services develop. Health technology and health technology assessment (HTA) have gained increasing attention in the NHS during this period, as part of a wider NHS Research and Development (R&D) Strategy. The strategy promotes a knowledge-based health service with a strong research infrastructure and the capacity to critically review its own needs. HTA is the largest and most developed of the programs within the strategy. It has a formal system for setting assessment priorities involving widespread consultation within the NHS, and a National Co-ordinating Centre for Health Technology Assessment. The strategy supports related centers such as the U.K. Cochrane Centre and the NHS Centre for Reviews and Dissemination. A hallmark of the HTA program is strong public participation. The United Kingdom has made a major commitment to HTA and to seeking effective means of reviewing and disseminating evidence.
International Journal of Technology Assessment in Health Care, 2011
The relationship between regulatory approval on the one hand and health technology assessment (HT... more The relationship between regulatory approval on the one hand and health technology assessment (HTA) and coverage on the other is receiving growing attention. Those responsible for regulatory approval, HTA, and coverage have different missions and their information requirements reflect these. There is nonetheless an increasingly popular view that improved communication and coordination between these functions could allow them all to be undertaken effectively with a lower overall burden of evidence requirements, thus speeding patient access to new products and reducing unnecessary barriers to innovation. This study summarizes the main points emerging from a recent discussion of this topic at the HTAi Policy Forum. After considering the roles of the various bodies, stakeholder perspectives and some current practical initiatives, those present at the Forum meeting discussed possible goals and challenges for improved interactions-in general and at specific stages of the product development life cycle. Opportunities for progress were seen in: continuing the dialogue to promote understanding and interaction between the different bodies and stakeholders; working to align scientific advice for manufacturers on the design and data requirements of pre- and post-marketing evaluation of products (specifically phase 2/3 and phase 4 trials for drugs); and extending the current dialogue to include discussion of product development to address unmet health needs.
International Journal of Technology Assessment in Health Care, 2013
Background: Identifying treatments that offer value and value for money is becoming increasingly ... more Background: Identifying treatments that offer value and value for money is becoming increasingly important, with interest in how health technology assessment (HTA) and decision makers can take appropriate account of what is of value to patients and to society, and in the relationship between innovation and assessments of value. Methods: This study summarizes points from an Health Technology Assessment International (HTAi) Policy Forum discussion, drawing on presentations, discussions among attendees, and background papers. Results and Conclusions: Various perspectives on value were considered; most place patient health at the core of value. Wider elements of value comprise other benefits for: patients; caregivers; the health and social care systems; and society. Most decision-making systems seek to take account of similar elements of value, although they are assessed and combined in different ways. Judgment in decisions remains important and cannot be replaced by mathematical approaches. There was discussion of the value of innovation and of the effects of value assessments on innovation. Discussion also included moving toward "progressive health system decision making," an ongoing process whereby evidence-based decisions on use would be made at various stages in the technology lifecycle. Five actions are identified: (i) development of a general framework for the definition and assessment of value; development by HTA/coverage bodies and regulators of (ii) disease-specific guidance and (iii) further joint scientific advice for industry on demonstrating value; (iv) development of a framework for progressive licensing, usage, and reimbursement; and (v) promoting work to better adapt HTA, coverage, and procurement approaches to medical devices.
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Papers by Chris Henshall